Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage: Diagnosis and Treatment

Status: Recruiting
Location: See all (33) locations...
Study Type: Observational
SUMMARY

Recent studies state that patients affected by aneurysmal subarachnoid hemorrhage (aSAH) today survive longer because they are treated early. Unfortunately, patients often develop chronic disabling neurological deficits at a rate that is still unacceptable given the progress in the specific treatment of this pathology and the volume of systems of neurological monitoring available to date in Italy. The main cause of unfavorable neurological outcome is delayed cerebral ischemia (DCI), often resulting from symptomatic vasospasm defined as delayed neurological ischemic deficit (DIND). The incidence of DIND is not defined and is difficult to diagnose early as there is no gold standard for identifying it, nor guidelines regarding the most effective treatment. Given these gaps, the primary objective of this study is to describe the incidence of DIND in patients affected by aSAH, collecting information regarding the diagnostic imaging (neurological symptom on clinical examination or alteration on instrumental monitoring). Secondary objectives will be to evaluate the different therapeutic strategies adopted in the different participating centers and compare these strategies to mortality and short- and long-term functional neurological outcome. Furthermore, as there are no data in the literature, the Investigators want to describe the indications, usefulness and intensity of treatment in the aSAH patient in case of monitoring of parenchymal intracranial pressure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral artery aneurysm confirmed by cerebral angiotomography or angiography of the intracranial vessels, with the need for admission to the Intensive Care Unit

• Signing the Informed Consent form to participate in the study according to current local regulations.

Locations
Other Locations
Italy
ASST Papa Giovanni XXIII
NOT_YET_RECRUITING
Bergamo
IRCCS Istituto delle Scienze Neurologiche
NOT_YET_RECRUITING
Bologna
ASST Spedali Civili
NOT_YET_RECRUITING
Brescia
Fondazione Poliambulanza
NOT_YET_RECRUITING
Brescia
ASST Cremona
NOT_YET_RECRUITING
Cremona
Azienda Ospedaliero-Universitaria Careggi
NOT_YET_RECRUITING
Florence
IRCCS Ospedale Policlinico San Martino
NOT_YET_RECRUITING
Genova
ASST Lecco - Ospedale A. Manzoni
NOT_YET_RECRUITING
Lecco
ASST Ovest Milanese - Ospedale di Legnano
NOT_YET_RECRUITING
Legnano
ASST Mantova
NOT_YET_RECRUITING
Mantova
ASST Fatebenefratelli Sacco
NOT_YET_RECRUITING
Milan
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
NOT_YET_RECRUITING
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Fondazione IRCCS Istituto Neurologico Carlo Besta
NOT_YET_RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
AOU Maggiore della Carità
NOT_YET_RECRUITING
Novara
Azienda Ospedale-Università di Padova
NOT_YET_RECRUITING
Padua
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Azienda Ospedaliera di Perugia
NOT_YET_RECRUITING
Perugia
Azienda Ospedaliera San Camillo Forlanini
NOT_YET_RECRUITING
Roma
Fondazione Policlinico Universitario A. Gemelli
NOT_YET_RECRUITING
Roma
Human Research Hospital
NOT_YET_RECRUITING
Rozzano
ASST Lariana Ospedale Sant'Anna
NOT_YET_RECRUITING
San Fermo Della Battaglia
IRCCS San Raffaele
NOT_YET_RECRUITING
Segrate
ASST Valtellina e Alto Lario
NOT_YET_RECRUITING
Sondrio
ASL Città di Torino - Ospedale San Giovanni Bosco
NOT_YET_RECRUITING
Torino
Azienda Sanitaria Universitaria Giuliano Isontina
NOT_YET_RECRUITING
Trieste
Azienda Sanitaria Universitaria Friuli Centrale
NOT_YET_RECRUITING
Udine
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
NOT_YET_RECRUITING
Varese
Azienda Ospedaliero Universitaria Integrata
NOT_YET_RECRUITING
Verona
Ospedale San Bortolo
NOT_YET_RECRUITING
Vicenza
Contact Information
Primary
Giuseppe Citerio, Professor, Head of Department
giuseppe.citerio@unimib.it
+390392334316
Backup
Clinical Research Coordination Office
ricerca.clinica@irccs-sangerardo.it
+390392339583
Time Frame
Start Date: 2024-09-28
Estimated Completion Date: 2026-10
Participants
Target number of participants: 1400
Treatments
aSAH group
Patients diagnosed with aneurysmal subarachnoid hemorrhage.
DIND group
Patients diagnosed with aneurysmal subarachnoid hemorrhage who develop delayed ischemic neurologic deficit.
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS San Gerardo dei Tintori

This content was sourced from clinicaltrials.gov